Remibrutinib Open Label Roll-over Post-trial Access Protocol

Recruiting now · Phase 3

Conditions studied: Indication of the Parent Protocol

In brief

Multi-center, open-label roll-over post-trial access protocol to provide remibrutinib treatment and collect long-term safety for up to three years for participants who are currently receiving remibrutinib treatment in a Novartis-sponsored study, who are benefiting from treatment with remibrutinib, and are unable to access remibrutinib treatment outside of a clinical study.

Key facts

Study ID

NCT07456891

Run by

Novartis Pharmaceuticals

People needed

648

Starts

2026-04-16

Expected to finish

2033-01-30

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has completed treatment per protocol in a Novartis study of remibrutinib (unless otherwise specified in a parent study protocol) in a dermatological or allergology indication.
• Participants, who derive benefit from the treatment with remibrutinib but have not completed the treatment in certain parent studies due to parent study termination by Novartis, may be eligible if the termination was due to reasons other than safety or lack of efficacy (e.g., technical / administrative reasons).
• Participant is deriving benefit from remibrutinib, investigator believes he/she would continue to derive benefit from remibrutinib and the benefit outweighs the risk, based on the investigator's judgement.
• Participant is unable to obtain access to the marketed remibrutinib formulation per local post study drug supply program, prescription and/or reimbursement guidelines.

You may not qualify if…

• Participants meeting any of the following criteria are not eligible for inclusion in this study.
• Participant has prematurely discontinued study treatment in the parent study.
• Use of prohibited medications

Where it is running

• Novartis Investigative Site — Sofia, Bulgaria (enrolling)
• Novartis Investigative Site — Sofia, Bulgaria (enrolling)
• Novartis Investigative Site — Varna, Bulgaria (enrolling)
• Novartis Investigative Site — Hamilton, Ontario, Canada (enrolling)
• Novartis Investigative Site — London, Ontario, Canada (enrolling)
• Novartis Investigative Site — Québec, Quebec, Canada (enrolling)
• Novartis Investigative Site — Verdun, Quebec, Canada (enrolling)
• Novartis Investigative Site — Brno, Czechia (enrolling)
• Novartis Investigative Site — Plzen Bolevec, Czechia (enrolling)
• Novartis Investigative Site — Prague, Czechia (enrolling)
• Novartis Investigative Site — Prague, Czechia (enrolling)
• Novartis Investigative Site — Bordeaux, France (enrolling)
• Novartis Investigative Site — Brest, France (enrolling)
• Novartis Investigative Site — Montpellier, France (enrolling)
• Novartis Investigative Site — Paris, France (enrolling)
• Novartis Investigative Site — Rouen, France (enrolling)
• Novartis Investigative Site — Gdansk, Poland (enrolling)
• Novartis Investigative Site — Gdansk, Poland (enrolling)
• Novartis Investigative Site — Krosno, Poland (enrolling)
• Novartis Investigative Site — Poznan, Poland (enrolling)
• Novartis Investigative Site — Poznan, Poland (enrolling)
• Novartis Investigative Site — Daegu, Dalseo Gu, South Korea (enrolling)
• Novartis Investigative Site — Suwon, Gyeonggi-do, South Korea (enrolling)
• Novartis Investigative Site — Dongjak Gu, Seoul, South Korea (enrolling)
• Novartis Investigative Site — Gwangju, South Korea (enrolling)

Full record on ClinicalTrials.gov

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